UPDATE: Oct. 28, 2019: BD reached an agreement Monday with state officials to suspend operations at its Covington, Georgia sterilization facility from Oct. 30 to Nov. 6, during which time the Georgia Environmental Protection Division will assess surrounding air quality when sterilization systems are not operating.
The approval of a consent order by Newton County Superior Court Judge Eugene Benton also "imposes fugitive emissions caps, requires mandatory reports, and imposes deadlines for installation of enhanced pollution controls at BD’s medical sterilization facilities in Covington and Madison," a statement from Governor Brian Kemp's office said.
BD said in a related statement it "does not expect disruption to product availability at this time."
Separately, the Illinois House Energy and Environment Committee planned to discuss a pair of bills that could lead to restriction or phasing out of ethylene oxide-based device sterilization in the state in a hearing Monday afternoon.
A Medline Industries plant in Waukegan, Illinois could be closed as a result, industry association AdvaMed said. Medline is facing lawsuits alleging it subjected nearby residents to elevated cancer risks.
AdvaMed President Scott Whitaker said in a statement the potential shutdown of that plant "will likely have a direct and devastating effect on the patients who are served by 135 Illinois hospitals as well as millions of patients across the country who depend on the safe, clean and critical surgical devices Medline sterilizes."
FDA is imploring medical device manufacturers and healthcare facilities alike to assess how their distribution and inventory could be impacted by “any potential downstream impacts” of ethylene oxide sterilization facility closures and communicate possible shortages to regulators.
The agency's latest statement Friday on disruption to sterilization processes comes days after Georgia State Attorney General Chris Carr filed a complaint to temporarily stop operations at a BD sterilization facility, which the medtech called "an unnecessary move."
- "It's important to note at this time there are no readily available processes or facilities that can serve as viable alternatives to those that use ethylene oxide to sterilize these devices," FDA wrote in the statement. "In short: this method is critical to our health care system and to the continued availability of safe, effective and high-quality medical devices."
FDA struck an urgent tone Friday, acknowledging supply disruptions stemming from past closures of Sterigenics ethylene oxide (EtO) sterilization facilities in Illinois and Georgia, and more importantly, possible further impact from the potential shutdown of a Georgia plant operated by BD as well as any other future interferences.
"The impact resulting from closure of these and perhaps more facilities will be difficult to reverse, and ultimately could result in years of spot or nationwide shortages of critical medical devices, which could compromise patient care," regulators wrote.
Ethylene oxide is the most common medical device sterilant, covering at least half of devices that require sterilization, and 20 billion of the devices sold in the U.S. each year, FDA said. The technique is commonly used for devices with numerous layers of packaging or hard-to-reach crevices, the agency added.
Facilities performing this type of sterilization have come under fire over concerns that nearby residents exposed to heightened EtO emissions may have higher risk of developing cancer. The public health catch-22 pits potential harm from those emissions against possible widespread shortages of lifesaving devices if the form of sterilization is restricted.
The medical device industry has awaited new rules from the U.S. Environmental Protection Agency related to ethylene oxide production that could affect sterilizers' ability to operate. Trade group AdvaMed has lobbied the agency to ensure those rules won't lead to device shortages.
With the future of some sterilization facilities in flux, FDA is urging device manufacturers to maintain open communication with the agency on possible supply disruptions. Unlike FDA’s Center for Drug Evaluation and Research, the Center for Devices and Radiological Health lacks the statutory authority to require manufacturers to fully disclose product shortages.
In its communication Friday, FDA went beyond device makers, encouraging hospitals to “work together and not hoard product or attempt to purchase larger quantities of devices beyond their normal purchase volume.”
Medical societies have also weighed in.
"Many complex medical devices, including but not limited to pacemakers and leads, angioplasty balloons, cardiac catheters, stents, and guiding sheaths, and other supplies and equipment used in the care of cardiovascular patients, currently rely upon EtO for proper sterilization to ensure patient safety," a letter submitted to FDA Monday from groups including the American College of Cardiology, Society of Interventional Radiology and American Society for Gastrointestinal Endoscopy, said.
The disruptions began with the February closure of a Sterigenics facility in Willowbrook, Illinois that performed sterilization for devices from companies like Boston Scientific and Medtronic, which followed scrutiny from the state Environmental Protection Agency. That closure resulted in a temporary shortage of Smiths Medical breathing tubes.
Sterigenics announced in late September it would not reopen the Willowbrook facility, citing an "unstable legislative and regulatory landscape" in the state. Earlier that month, Sterigenics also temporarily closed a location in Atlanta.
Georgia may lose another sterilization facility, with Attorney General Carr’s office accusing BD of releasing quantities of ethylene oxide emissions violating state air quality rules, which "upon further investigation has been determined to have been caused by a lack of diligence and prolonged operator error rather than an equipment malfunction," the AG said in a press release Monday tied to the complaint.
The AG said the plant should be closed until BD demonstrates it has properly trained staff, completed corrective actions and installed necessary pollution control equipment. The office added that "BD’s lack of response to these recent violations" is “in stark contrast to the response that Governor Kemp and EPD have gotten from other similar medical commercial sterilizers in Georgia."
BD responded Monday with a statement saying, "The Attorney General’s action is an unnecessary move given the company’s high level of cooperation and is inconsistent with our continued dialogue with the state to implement voluntary improvements at our Covington facility," adding it is "concerned about the risk the State of Georgia’s actions poses to the patients our products serve in Georgia and nationwide."
Effects of plant shutdowns are immediate, Scott Whitaker, president of industry association AdvaMed, warned in a statement Wednesday.
"Even those entering intensive care units (ICUs) in the coming days could see delays in their care or lack of availability because every patient requires a catheter that must be sterilized with EtO," he said.
Still, FDA said it shares "the public’s objective to reduce over-reliance" on the chemical for device sterilization, pointing to two ‘innovation challenges’ it wrapped up in mid-October, soliciting ideas for sterilization alternatives to EtO as well as strategies to cut emissions.
FDA will further address ethylene oxide sterilization concerns in an advisory committee meeting in November.